Systems and methods for enhancing preparation and completion of surgical and medical procedures

ABSTRACT

Systems and methods for preparing and completing surgical and medical procedures. In particular, kits are provided for improving preparation and completion time for a medical or surgical procedure in which the kit includes modularized compartments containing sterilized medical or surgical equipment and wherein the medical or surgical equipment is organized and/or ordered within the kit to generally correspond to the sequence of steps of the medical or surgical procedure. The kit is particularly applicable to recanalization procedures for stroke patients as well as revascularization procedures for acute myocardial infarction patients where a kit enables faster preparation and completion of these procedures.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation under 37 CFR 1.53(b) of prior U.S.patent application Ser. No. 14/870,705 filed Sep. 30, 2015 and claimsthe benefit of U.S. patent application Ser. No. 14/005,167 filed Sep.13, 2013, which is now U.S. Pat. No. 9,186,217, and claims the benefit(35 U.S.C. § 120 and 365(c)) of International ApplicationPCT/CA2013/000533 filed Jun. 3, 2013, which designated inter alia theUnited States and which claims the priority of U.S. Provisional PatentApplication 61/655,854 filed Jun. 5, 2012, the entire contents of eachapplication are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to systems and methods for preparing andcompleting surgical and medical procedures. In particular, the inventionrelates to kits for improving preparation and completion time for amedical or surgical procedure in which the kit includes modularizedcompartments containing sterilized medical or surgical equipment andwherein the medical or surgical equipment is organized and/or orderedwithin the kit to generally correspond to the sequence of steps of themedical or surgical procedure. The kit is particularly applicable torecanalization procedures for stroke patients as well asrevascularization procedures for acute myocardial infarction patientswhere a kit enables faster preparation and completion of theseprocedures.

BACKGROUND OF THE INVENTION

Many surgical and medical procedures are sophisticated and/or complexprocedures that require substantial and coordinated contributions from anumber of different medical practitioners including physicians, nurses,technologists and other assistants.

In particular, many procedures require that teams of medicalpractitioners work together through an orchestrated sequence of steps toensure that best practices for the delivery of a particular procedure isattained in accordance with a particular standard of patient care. Forexample, most surgical and medical procedures follow a logical sequenceof steps that may involve any combination of assessment, diagnosis,imaging, preparation, procedure and follow-up.

Importantly, in many scenarios, while best practices may suggest thatpreferred procedures be followed, the particulars of an emergencymedical condition may limit the ability of the medical team to completethe preferred steps either because of time constraints and/or theavailability of equipment and/or tools to enable those steps.

For example, in the case of assessing and treating stroke patientssuffering from cerebral arterial blockage, time to recanalization ofcerebral arteries is a critical factor in patient outcome where theextent of brain damage may be significantly affected by the time takento effect recanalization.

That is, any time saved during the procedures to assess, diagnose, imageand treat a stroke patient may have significant effects on the status ofthe patient. While different steps in the process continue to beimproved, for example, imaging and recanalization technologies continueto improve, other steps within the overall assessment and treatmentprotocols can be inefficient.

More specifically, the ability to achieve intra-arterial (IA)recanalization keeps getting better as demonstrated by studies (such asSWIFT, TREVO and others) and based on availability of newer devices suchas Solitaire™, Penumbra™, or Trevo™. In most acute ischemic strokepatients, core (tissue which is already dead) expands into penumbra(tissue at risk of dying if reperfusion is not achieved emergently) overa period of time. While the ability to measure core is quite good, it isnot perfect and the ability to measure how fast core is growinggenerally cannot be readily quantified. As such, it remains important toachieve recanalization as quickly as possible.

In a typical scenario, a patient having a stroke will go through thefollowing sequence of steps. These will typically include recognizingsymptoms, calling 911, and getting to the hospital and importantly thecorrect hospital. At the hospital, the patient will undergo clinicalevaluation followed by imaging which will determine if the stroke isischemic or hemorrhagic. If the stroke is ischemic, further imaging suchas CTA (computer tomography angiography), CTP (computer tomographyperfusion) and/or MRI (magnetic resonance imaging) may be undertaken. Ifthere is large vessel proximal occlusion, a decision based on a numberof factors will determine if the patient goes to a catheter lab(Cath-Lab) to attempt intra-arterial recanalization. Generally speakingCath-Lab procedures are done for bad, potentially disabling strokes.

When the decision is made to initiate surgical treatment, a number offactors will come into play that must all be managed to enable treatmentin what is a complex emergency situation. These factors include the timeof day (may be after regular staffing hours), the assembly of differentteams and the requirements for patient monitoring, anesthesia, consentand patient preparation for the procedure.

Due to the number of people involved as well as the surgical equipmentinvolved, the setting up for the procedure is often confusing and timeconsuming. For example, there are at least 50 pieces of separateequipment that need to be opened from individual packets in order for atypical recanalization procedure to be initiated and each packet must beopened and/or prepared in a particular order. Catheters and other linesneed to be flushed and attached to a pressure line in such a way that noair remains in the lines.

Further still, particularly when such procedures are being conducted asan emergency outside normal staffing hours, different members of theteam may reach the lab at slightly different times. Depending on thetime of arrival and the particular training of the team members, it maybe difficult for certain team members to initiate the preparatory stepsdue to the lack of training to assemble and/or undertake such steps. Anydelays in preparing the patient and/or the equipment will result indelays in initiating and completing the medical procedure itself.Moreover, medical teams do not want to be assembling or looking forequipment in the middle of the night when the procedure may be required.In addition, it may be desired that the procedure is performed at ahospital or treatment facility where the procedure is not routinelyperformed with the result being that a physician/medical team may not befamiliar with the layout of an operating room and/or the storagelocations of the equipment. As such, there is a need for equipment to betransportable in a convenient form so as to minimize time delays underthese conditions.

In other words, there can be significant delays in the time from patientdiagnosis to the commencement and completion of a recanalizationprocedure due to the time required to organize and deploy the surgicalequipment.

Similarly, the same issues apply to the diagnosis and treatment of acutemyocardial infarction patients. As with stroke patients, time is acritical factor in diagnosing and treating such patients. Also, thepatient preparation and treatment procedures for recanalization andrevascularization procedures are substantially similar in certainrespects. That is, in undertaking treatment procedures in both acutestroke and myocardial infarction patients, catheter procedures areutilized to gain access to affected vessels and to effect treatment ofthose vessels by clot removal or coronary artery opening by balloonangioplasty and/or stenting.

A review of the prior art indicates that various surgical kits have beenthe subject of patent protection. However, the prior art does considerand does not teach or suggest a solution to the technical problem ofmore efficiently preparing for and undertaking an recanalization andrevascularization procedures.

Examples of past surgical kits are discussed briefly below.

U.S. Pat. No. 7,288,090 describes an electrophysiological procedure kitcontaining the internal indifferent electrode device, a surgical probeand other tools or devices that may be required for a procedure.

U.S. Patent Application Publication No. 2011/0071572 describes a sterilesingle-use disposable orthopedic surgery kit for the internal fixationof fractured bones. The kit includes a single bone plate precontouredand sized to match the patient's anatomic shape. The kit includes abriefcase-like container that has partitions for compartmentalization,with all the components visible and accessible when the container isopen.

U.S. Pat. No. 7,331,462 describes a kit management system for use inmicrosurgery that includes a plurality of tubing, surgical instruments,connectors, an instrument tray, a connector tray, and a tubingorganizer. The tubing organizer secures and separates the tubing in aspaced relationship as needed during microsurgery.

U.S. Patent Application Publication No. 2003/0159969 and U.S. Pat. No.7,401,703 describe a surgical kit including a tray having a plurality ofplanar surfaces with recesses for holding surgical implements. Theplanar surfaces are vertically offset from one another such that itemsin the top surface must be removed before items below can be accessed.

U.S. Pat. No. 4,501,363 describes a surgical kit having a pair of trayswherein one tray is received inside the other. Each tray includes aplurality of embossments in its bottom for receiving various surgicalsupplies. After the completion of the surgery, the inner tray is flippedover and set on top the outer tray to form a receptacle forpost-operative materials.

U.S. Patent Application Publication No. 2011/0186456 describes a systemof surgical instruments for knee surgery having various containers.Size-specific instruments are grouped in the containers according tosize, such that once it is determined that a certain size of instrumentsare needed for a specific surgery, only the container(s) containing thenecessary size of instruments needs to be opened.

U.S. Pat. No. 5,868,250 describes a tray for dispensing and receivingsurgical equipment. The tray includes a bar for holding surgicalinstruments, particularly sharp instruments, that pivots upwardly into araised position to allow the instruments to be easily removed from andreturned to the bar. The bar may also be hollow to allow antisepticsolution to be pumped through it for sterilizing the instruments.

U.S. Patent Application Publication No. 2010/0274205 describes a woundtreatment kit comprising three containers divided by the order of stepsfor treating a wound, specifically 1) preparation; 2) dressing; and 3)sealing.

U.S. Patent Application Publication No. 2002/0185406 and U.S. Pat. No.7,100,771 describe a sterile pain management kit containing the primarymedical supplies needed for performing a continuous nerve blockprocedure.

U.S. Pat. No. 8,240,468 describes a pre-packaged medical deviceincluding a tray for supporting the medical device, such as a bloodcollection set including a needle assembly and a tube holder.

U.S. Pat. No. 6,588,587 describes a packaging system for medical devicesand surgical components used in heart by-pass surgery.

U.S. Pat. No. 6,412,639 describes a medical procedure kit containingsurgical tools and medical adhesive. The medical adhesive may beindependently sterilized and wrapped from the other surgical tools inthe kit.

U.S. Pat. No. 4,523,679 describes a pre-sterilized medical procedure kitthat contains a first unit pre-sterilized by ethylene oxide and a secondunit containing a heat sterilized vial of medicament agent that isincompatible with ethylene oxide sterilization.

In view of the foregoing, there continues to be a need for systems andmethodologies that address the foregoing problems with regards to IArecanalization and revascularization procedures and that specificallyenable a medical team to reduce the total time that may be required tocomplete these procedures. In particular, there has been a need forsystems and methodologies that permit members of a medical team toinitiate the preparatory steps of a complex recanalization orrevascularization procedure without requiring the assembly of thecomplete medical team. More specifically, there has been a need formodularized bundles of groups of recanalization or revascularizationsurgical equipment that enables different members of a surgical team toquickly and efficiently have access to equipment used in theseprocedures and where the layout of the modularized bundles logicallycorresponds to steps of the procedure.

SUMMARY OF THE INVENTION

In accordance with the invention, there is provided systems andmethodologies to initiate the preparatory steps of a complex medical orsurgical procedure and particularly recanalization and revascularizationprocedures without requiring the assembly of the complete medical team.

In accordance with a first embodiment, there is provided a modular kitfor decreasing preparation and surgical time for a recanalization orrevascularization procedure in the treatment of acute stroke and acutemyocardial patients comprising: at least one tray having a plurality ofcompartments containing a plurality of equipment modules containingsterilized surgical equipment to conduct individual steps of theprocedure, the individual steps including surgical site preparation,tube and catheter flushing, and arterial access steps of the procedure.In one embodiment, the equipment modules include a surgical sitepreparation module, a tube and catheter flushing module and an arterialaccess module. Such equipment can include tube and catheter equipment toconduct a recanalization or revascularization procedure.

In one embodiment, the kit includes outer packaging providing a sterileseal to the at least one tray and the equipment modules. The at leastone tray may include a lower tray stackable with an upper tray with theupper tray including surgical site preparation equipment or the lowertray may include the surgical site preparation equipment. The kit mayalso be a single tray or a combination of stacked and unstacked trays.

In one embodiment, the tube and catheter flushing module includes atleast one catheter flushing manifold, the catheter flushing manifoldincluding a first port for operative connection to a flushing system andat least two catheter openings for connection to catheters and whereinactivation of the flushing system enables simultaneous flushing of eachconnected catheter. In one embodiment, the at least two catheteropenings will have different diameters.

In one embodiment, the kit includes a bowl compartment integrally formedwith the at least one tray. The bowl compartment may support a separablebowl. In one embodiment, the bowl compartment includes a sterile seal onan upper surface of the at least one tray and the bowl compartmentsupports liquid within the tray.

In one embodiment, each of the surgical site preparation module, tubeand catheter flushing module and arterial access module are separatetrays separable from one another.

In preferred embodiments, the surgical site preparation module includescleaning and draping equipment and the tube and catheter flushing moduleincludes catheter flushing equipment.

In one embodiment, the procedure module includes intra-arterialrecanalization equipment, the intra-arterial recanalization equipmentincluding a plurality of catheters for accessing neck and brain vesselsand clot retrieval. In another embodiment, the procedure module includesan acute myocardial infarction (MI) equipment module, the acute MIequipment including a plurality of catheters for accessing neck andcoronary arterial vessels and a plurality of microcatheters, microwires,angioplasty balloons and stents for dilating of stenosed coronaryvessels.

In yet another embodiment, each catheter within the procedure moduleincludes a pre-attached rotating hemostatic valve (RHVs) or three-waystop-cock.

In a further embodiment, the procedure module includes at least two clotretrieval devices individually sealed within the procedure module toenable collection and re-use of equipment unused in the procedure. Thekit may also include an equipment return module having labelling andpackaging for packaging unused equipment for return to a manufacturer.

In one embodiment, the surgical equipment in the each of the surgicalsite preparation module, the tube and catheter flushing module andarterial access module include module packaging only and are notindividually packaged.

In another aspect, the invention provides a method for decreasingpreparation and surgical time for a recanalization or revascularizationprocedure in the treatment of acute stroke and acute myocardialinfarction patients comprising the steps of: a. accessing a modular kithaving at least one tray having a plurality of compartments containing aplurality of equipment modules containing sterilized surgical equipmentto conduct individual steps of the recanalization or revascularizationprocedure, the compartments containing surgical site preparationequipment, tube and catheter flushing equipment, arterial accessequipment and recanalization or revascularization equipment; b.preparing the surgical site using the surgical site preparationequipment; and, c. conducting tube and catheter flushing of therecanalization or revascularization equipment.

In another embodiment, step c. includes conducting simultaneous flushingof at least two tubes or catheters of the recanalization orrevascularization equipment.

In yet another embodiment, the method further comprises the step ofproviding an equipment return module within the kit having labelling orpackaging and returning unused procedure equipment to a manufacturerusing the labelling or packaging.

The various features of novelty which characterize the invention arepointed out with particularity in the claims annexed to and forming apart of this disclosure. For a better understanding of the invention,its operating advantages and specific objects attained by its uses,reference is made to the accompanying drawings and descriptive matter inwhich preferred embodiments of the invention are illustrated.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings:

FIG. 1 is an isometric view of a modularized equipment tray of anintra-arterial (IA) recanalization kit in accordance with one embodimentof the invention;

FIG. 1A is an end view of a modularized equipment tray of anintra-arterial (IA) recanalization kit in accordance with one embodimentof the invention;

FIG. 1B is an end view of a two-layer modularized equipment tray of anintra-arterial (IA) recanalization kit in accordance with one embodimentof the invention;

FIG. 1C is an end view of a three-layer modularized equipment tray of anintra-arterial (IA) recanalization kit in accordance with one embodimentof the invention;

FIG. 1D is an end view of a hybrid modularized equipment tray of anintra-arterial (IA) recanalization kit in accordance with one embodimentof the invention;

FIG. 2 is an isometric view of typical surgical site scrubbing equipmentfor inclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 3 is an isometric view of typical surgical drapes for inclusion ina module of a recanalization kit in accordance with one embodiment ofthe invention;

FIG. 4 is an isometric view of typical arterial access equipment forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 5 is an isometric view of typical pressure bag connecting tubes forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 6 is an isometric view of a flushing manifold for inclusion in amodule of a recanalization kit in accordance with one embodiment of theinvention;

FIG. 7 is an isometric view of typical neck vessel access equipment forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 8 is an isometric view of typical brain vessel access equipment forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 8A is an isometric view of a typical clot retrieval device forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 9 is an isometric view of typical miscellaneous equipment forinclusion in a module of a recanalization kit in accordance with oneembodiment of the invention;

FIG. 10 is an isometric view of a typical bowl for inclusion in a moduleof a recanalization kit in accordance with one embodiment of theinvention;

FIG. 11 is a conceptual and side schematic view of an intra-arterial(IA) recanalization kit with exterior packaging in accordance with oneembodiment of the invention; and

FIG. 12 is a view of a conceptual time layout of the key steps of an IArecanalization procedure.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the figures, systems and methodologies to initiate thepreparation for and completion of intra-arterial (IA) recanalization andrevascularization procedures for acute ischemic stroke and acutemyocardial infarction patients are described. For the purposes ofdescription, the invention is described with primary reference to IArecanalization or revascularization procedures. As discussed within thisdescription, it is understood that the invention can be applied to otherprocedures.

The system generally provides a multi-compartment, modularized kitcontaining the required equipment to prepare a patient for an IArecanalization procedure and to undertake the procedure wherein theequipment is ordered within the modularized kit to generally correspondto the sequence of steps of an IA recanalization procedure. That is, andin accordance with an IA recanalization procedure, the equipment isgenerally ordered to enable surgical site preparation, tube and catheterflushing, arterial access and procedure completion. Importantly, it isunderstood that the specific medical or surgical equipment within themodularized kit may be varied in accordance with changes in the medicalor surgical equipment that may be utilized for such a procedure and anyreference in this application to specific medical equipment (forexample, as listed in Appendix A) is for illustrative purposes only andthat workers skilled in the art may substitute alternate equipmentwithout departing from the scope of the invention as defined by theclaims.

In the context of this description, the term “modular” or an “equipmentmodule” generally means the organization of functional groups of medicalequipment that may be used for a particular step or series of stepswithin an overall medical procedure. However, the term modular orequipment module does not necessarily mean a specific compartment orspatially separated area within a larger collection or organization ofequipment used for the overall medical procedure. That is, a singlemodule of equipment may be located in one compartment and compriseseveral pieces of equipment. A single module of equipment may also belocated in more than one compartment and comprise one or more pieces ofequipment in each compartment. A single module of equipment may includemore than one compartment that are physically separable from one anotheror be integral with one another.

As shown in the Figures, the kit 10 includes one or more trays 12 havingcompartmentalized sections 14 for containing medical equipment for a)preparing a patient for an IA recanalization procedure and b)undertaking the procedure. FIGS. 1 and 1A show an embodiment of the kitwith a single unstacked tray 12 a, FIG. 1B shows a stacked tray 12 bembodiment with two layers, FIG. 1C shows a stacked tray 12 b embodimenthaving three layers and FIG. 1D shows a hybrid embodiment showing acombination of two stacked 12 b and unstacked 12 a trays. Generally, inthe context of the description, a tray is a supporting base structureused to support and/or contain the kit modules.

Regardless of the embodiment, each tray includes at least onecompartment 14 for containing specific equipment for preparing a patientfor and performing IA recanalization. The trays and/or compartments arelaid out in a logical order that generally corresponds to the sequenceof steps of preparing for and undertaking an IA recanalizationprocedure. In one embodiment, containing multiple trays, the trays maybe physically separated for distribution to different locations in anoperating room to enable different members of the team to have access tothe specific equipment they require.

FIGS. 2-10 show various groups of equipment that may be packaged asmodules to enable each of the preparation and surgical steps to becompleted. FIG. 12 is an overview of the time sequence of thepreparation and surgical steps. In the context of this description, asnoted above, a module may include one or more pieces of surgicalequipment. In one embodiment, each piece of surgical equipment may beindividually packaged in a sterile package and may be collectivelypackaged within outer packaging. Each module of equipment is locatedwithin a tray in one or more compartments 14. If equipment of one moduleis located in more than one compartment, the compartments are preferablyadjacent one another and/or part of a common tray. In one embodiment,modules of equipment are individual packaged and in one embodiment asdescribed in greater detail below, valuable pieces of pieces areindividually packaged so as to enable their return to a manufacturer inthe event that they are not used during the procedure.

FIG. 2 shows surgical site cleaning equipment that may be included in afirst module. The first module may include cleaning equipment such asskin cleaning equipment 2 a and a disposable electric razor (not shown).

FIG. 3 shows typical surgical drapes 3 a that are applied over thesurgical site and that may be included in the first module or a separatemodule.

FIG. 4 shows arterial access equipment and may include a scalpel 4 a,syringe preloaded or along with local anesthetic 4 b, puncture needle 4c, forceps 4 d and small introducer wire 4 e. The arterial accessequipment is preferably contained in a distinct module.

FIG. 5 shows typical connecting tubes 5 a for pressure bags (not shown)that enable connection of pressure bags to tube flushing equipment.

FIG. 6 shows a manifold 5 a that enables simultaneous flushing ofmultiple tubes of different diameters. The manifold is described ingreater detail below. The connecting tubes and manifolds may becontained in a single or separate module.

FIG. 7 shows neck vessel access equipment and may typically include aballoon guide catheter 7 a, one or more pre-shaped diagnosticcatheter(s) 7 b and guide wire 7 c. Each of the balloon guide catheter 7a, pre-shaped diagnostic catheter 7 b and guide wire 7 c are preferablycontained within a single module. These would vary in size and shape ifit were being designed for coronary access.

FIGS. 8 and 8A shows brain vessel access and clot retrieval equipmentand may typically include a microcatheter 8 a and microwire 8 b.Generally the microwire 8 b is used to direct the microcatheter 8 asafely beyond the site of the clot/thrombus in the brain vessel with themicrowire subsequently being removed. Thereafter, the clot retrievaldevice 8 c is introduced through the microcatheter to be deployed acrossthe clot. As known to those skilled in the art, there may be variationsin the actual clot retrieval device. For example, clot retrieval may beconducted by applying suction and pulling the clot into themicrocatheter. Similarly these would be a different set of components ifan acute myocardial infarction was being treated and would generallyinclude microwires, angioplasty balloons and stents (not shown).

FIG. 9 shows miscellaneous equipment including various sizes syringes 9a, 9 b, rotating hemostatic valves 9 c, 3-way stop cocks 9 d, gauze 9 eand steri-strips 9 f contained in a single module. The miscellaneousequipment is preferably part of a distinct module separable from theother modules.

FIG. 10 shows a typical surgical bowl 10 a. The bowls may include atleast one large bowl used for keeping wires and catheters and at leastone smaller bowl for holding contrast agent and/or saline. As shown inFIGS. 1, 1A, 1B, 1C and 1D, individual trays may contain one or morecompartments 10 a, 10 b, 10 c, 10 d for bowls. Physical bowls may beseparable from a tray or may be integrally formed within the tray. Inone embodiment as shown in FIG. 1D, a large bowl 10 a (i.e. a deeperbowl) may be formed as part of a “double height” tray 12 a, whereas assmaller bowl 10 b (e.g. for holding contrast agent) may be formed as“single height” tray 12 c. Non-separable bowls may include a sterileseal 10 e covering the bowl opening. The trays may also be used assupports for any separable bowl.

The foregoing FIGS. 2-10 show various generic equipment used in atypical IA recanalization procedure. However, it is understood that eachmodule may include other generic and more specific equipment includingbut not limited to additional tubing, dilators, sheaths, stentretrievers, other wire, contrast filled syringes, sponges, diagnosticcatheters, balloon guide catheter introducer, balloon guide catheter,Shuttle™ (Cook Medical), introducer (or similar) and Shuttle™ (orsimilar) (Cook Medical).

In addition, in one embodiment of the kit, allowances for differentpatient sizes is made. For example, it is preferred that more than onediagnostic catheter be included to allow for variance in the aortic archanatomy of a patient. Similarly more than one microcatheter or microwiremay be included to allow for variance in intracranial anatomy. Similarlymore than one clot retrieval devices of varying sizes may be included toallow for variance in clot length. Also, given that clot retrievaldevices are the most expensive part of the kit, in one embodiment, thedifferent clot retrieval devices are individually sealed within the kitto allow for the collection and re-use of equipment that are not usedfor the procedure. For example, unused clot retrieval equipment can bereturned to the manufacturer or supplier for re-packaging within a newkit. In this regard, the kit may also include an equipment return modulein the form of pre-addressed courier labels and/or return packaging thatenables the medical team to package unused equipment (particularly highvalue equipment) at the end of the procedure for return to themanufacturer or supplier. Upon receipt of unused equipment, themanufacturer will repackage such equipment for inclusion in another kit.As such, the hospital/facility returning equipment to the manufacturercan receive a credit against the original purchase price of the kit.

As shown in FIG. 11, in a three-tray stacked configuration, each of thethree compartment layers may be contained in a larger sealable package20 having a body 20 a and removable lid 20 b that provides and ensuressterility. In this embodiment, the kit is generally sized to fit onstandard operating room tables such that the compartment layers can beremoved from the larger package and moved to a desired location in theoperating room or spread out on operating room table.

In operation, the kit 10 is available to medical teams in atreatment/operating room. The kit is placed on a table and the outersealed package is opened to enable access to individual modules.Depending on the embodiment, individual modules may be separated toenable different team members to have close access to the specificequipment they require at different locations.

As shown in FIG. 12, each of the modules including a surgical sitepreparation module, tube and catheter preparation module, arterialvessel access module, procedure module, and optional miscellaneousequipment module, wound closure and equipment return module are shown inrelation to a typical time sequence. That is, initially, the medicalteam will access the skin preparation equipment (FIG. 2) to shave andclean the IA access locations. Drapes (FIG. 3) are applied to thesurgical sites.

Pressure bag preparation utilizing equipment within the tube andpreparation module is initiated either simultaneously with surgical sitepreparation or shortly after. Pressure bag preparation generallyincludes the steps of inserting saline bags within pressure pumps toallow slow forward flow of saline through the groin sheath, guidecatheter and microcatheter so as to prevent reflux of blood into thesecatheters.

After the patient is draped and the pressure bags prepared, the punctureequipment (FIG. 4) from the arterial access module is utilized toanesthetise the puncture area (preferably the groin) and effect thepuncture for catheter insertion.

All catheters, wires, microcatheters, microwires and sheaths are flushedprior to use using equipment from the tube and catheter preparationmodule and procedure module. This may be done directly with a salinefilled syringe or with the use of the manifold 6 a.

Catheter preparation generally requires careful flushing of thecatheters. As in a typical IA procedure, multiple catheters will need tobe prepared, each of which, if flushed individually requires an additiveamount of time to complete. Hence, in a preferred embodiment, the kitwill include a multiflush system in the form of a manifold 6 a (FIG. 6)enabling multiple catheters to be simultaneously flushed and therebysave time in the procedure.

The manifold 6 a will generally include a first fluid conduit 6 genabling fluid from a flushing system (e.g. a saline filled syringe 9 a)to be simultaneously flushed through each connected catheter.Importantly, as the flow resistance may be different for each catheter,the manifold will include openings and connectors (6 b-6 f) of varyingsizes to enable each catheter to be individual connected and ensure thateach catheter is adequately flushed. As well, a separate manifold systemmay also be included for the microcatheter, microwire, and clotretrieval devices etc. (FIG. 8, 8A) for those devices that aremanufactured in a spiral tube and need to be flushed on the outside andthe inside. As mentioned above, the manifold allows for thesedifferences so that all of these spaces are adequately flushed atsubstantially the same rate.

Rotating hemostatic valves (RHVs) and three-way stop cocks may also bepre-attached to the catheters and microcatheters at appropriate placesthereby obviating the need for separately flushing these and having toattach them. Importantly, by having the RHVs and stop cocks pre-attachedcan save significant time in the preparation of the catheters for theprocedure which can reduce the time to complete the procedure. The RHVsand/or three-way stop-cocks may be adjusted to ensure that the flowresistance through each catheter is substantially the same so that theprogression of flushing fluid through each catheter occurs at roughlythe same rate. The openings (6 b-6 f) of a manifold will preferably beprovided with removable caps (not shown) so that if all openings do notrequire a catheter to be attached, that opening will remain sealed.

As different physicians and teams may have different requirementsdepending on their specific practices, different kit configurations maybe assembled from typical equipment. Typical equipment for IA proceduresis listed in Appendix A.

A miscellaneous equipment module containing miscellaneous equipment, awound closure module to enable wound closure at the end of the procedureand/or an equipment return module may also be included.

Furthermore, as noted above, as different patients have differentanatomies, a “standard” kit may include additional sizes of components.

In another aspect of the invention, kits may be “custom” designed bymedical teams. In this case, specific trays of equipment may be selectedfrom an inventory of equipment, wherein the medical team/physician isable to assemble a specific package of equipment through online accessto a website allowing physicians to design a specific kit from availableinventories of equipment.

Importantly, kits can also provide physicians with the opportunity totravel between medical facilities to conduct procedures. That is, giventhe acuity of various medical situations and the level of specializationrequired to do certain procedures, physicians may take call for multiplehospitals where variations in equipment, staff and other parameters maybe present and could present problems in the timely delivery orexecution of a procedure. In such situations, physicians trained toconduct particular procedures could carry one or more kits and thus beable to efficiently conduct the procedure without necessarily having toknow the layout and workings of different facilities. That is, byknowing that the kit contains all the necessary equipment, the physicianwill be able to carry out the procedure with less dependence on an‘unfamiliar’ team. This may also obviate the need to move patientsbetween hospitals by ambulance which is substantially more expensive andtime consuming than having a physician move between hospitals.

Further still, the kit will enable procedures to be conducted in otherareas within a facility in the event that equipment failure, naturaldisasters or other factors necessitate the need to conduct proceduresoutside a typical location.

Further still, the kit will allow for a greater degree ofstandardization across different teams within the same center, acrossvarying levels of training and across various centers. Thisstandardization is likely to result in further increase the efficiencyof treatment for a number of procedures.

OTHER PROCEDURES

Importantly, as discussed above, the present invention may be utilizedin other procedures in which different modules of equipment may beassembled.

In addition, it should be noted that revascularization techniques andrecanalization techniques may be applied to both acute stroke and acuteMI patients depending on the particular pathology of the patient.

SUMMARY

In summary, the present invention seeks to provide time savings tomedical teams in acute situations and particularly to present medicalequipment to personnel in the order that it is needed and to prevent theneed to look for or assemble equipment. In addition, the invention seeksto reduce the time that may be required to prepare specific equipmentfor a procedure. In addition, use of the invention can improve trainingfor specific procedures as well as improve standardization of proceduresacross different medical facilities which will lead to improved patientoutcomes and lower the costs of delivering particular medical services.

While specific embodiments of the invention have been shown anddescribed in detail to illustrate the application of the principles ofthe invention, it will be understood that the invention may be embodiedotherwise without departing from such principles.

APPENDIX A

Representative List of Current Equipment Used in IA RecanalizationProcedures

1. Cleaning solution—2

2. Large drape with holes—1

3. Large drape to cover feet end—1

4. Several small absorbent drapes

5. Puncture needle

6. Scalpel

7. Syringe along with or preloaded with topical anesthetic

8. Puncture wire

9. Sheath with dilator

10. 3 pressure bags

11. 3 pressure pumps

12. 3 connecting lines

13. Guiding catheter sheath (Shuttle™ or equivalent) with introducer

14. Balloon guide catheter with introducer

15. Diagnostic catheters to allow access beyond the aortic arch orcoronary guide catheters

16. Many different syringes of different sizes (8)

17. Steri strips

18. Microcatheter (Rebar 18™ or equivalent)

19. Microwire

20. Clot Retrieval Device or angioplasty balloon or balloon mounted/selfexpanding stent

21. Rotating hemostatic valves—4

22. 3 way valves—4

23. Torque device—2

24. Arterial closure device: Angioseal™ or equivalent

25. Big bowl (to hold all the wires)

26. Small saline bowl

27. Contrast bowl

28. Discard bowl

What is claimed is:
 1. A method of providing a modularized bundle ofequipment for a recanalization procedure for decreasing preparation andsurgical time for a recanalization procedure in the treatment of acutestroke, the method comprising the steps of: incorporating at least onetray having a plurality of compartments containing a plurality ofequipment modules including a surgical site preparation modulecontaining sterilized surgical equipment for surgical site preparation,and an arterial access module for a recanalization procedure; andincorporating the compartments with outer packaging to provide a sterileseal to the equipment modules enabling members of a surgical team toinitiate preparatory steps of the recanalization procedure withoutrequiring assembly of a complete medical team, the surgical sitepreparation module having at least one compartment containing cleaningand draping equipment including at least one surgical drape for a distalarterial access site and cleaning solution, the arterial access modulehaving at least one compartment containing equipment including at leastone of a scalpel, a local anesthetic syringe, local anesthetic, apuncture needle, forceps and an introducer wire.
 2. A method as in claim1, further comprising the step of incorporating a tube and catheterflushing module within the modularized bundle.
 3. A method as in claim2, further comprising the step of incorporating a procedure equipmentmodule including tube and catheter equipment to conduct a recanalizationprocedure within the modularized bundle.
 4. A method as in claim 3,wherein the procedure equipment module includes intra-arterialrecanalization equipment, the intra-arterial recanalization equipmentincluding a plurality of catheters for accessing neck and brain vesselsand clot retrieval.
 5. A method as in claim 3, wherein each catheterwithin the procedure equipment module includes a pre-attached rotatinghemostatic valve (RHVs) or three-way stop-cock.
 6. A method as in claim3, wherein the procedure equipment module includes at least two clotretrieval devices individually sealed within the procedure equipmentmodule to enable collection and re-use of equipment unused in theprocedure.
 7. A method as in claim 6, further comprising providing anequipment return module having labeling and packaging for packagingunused equipment for return to a manufacturer.
 8. A method as in claim2, wherein the tube and catheter flushing module includes at least onecatheter flushing manifold, the catheter flushing manifold including afirst port for operative connection to a flushing system and at leasttwo catheter openings for connection to catheters and wherein activationof the flushing system enables simultaneous flushing of each connectedcatheter.
 9. A method as in claim 8, wherein the at least two catheteropenings have different diameters.
 10. A method as in claim 2, whereineach of the surgical site preparation module, tube and catheter flushingmodule and arterial access module are separate trays separable from oneanother.
 11. A method as in claim 10, wherein the tube and catheterflushing module includes catheter flushing equipment.
 12. A method as inclaim 2, wherein surgical equipment in each of the surgical sitepreparation module, the tube and catheter flushing module and thearterial access module include module packaging only and are notindividually packaged.
 13. A method as in claim 1, wherein the at leastone tray includes a lower tray stackable with an upper tray and theupper tray includes the surgical site preparation module.
 14. A methodas in claim 1, wherein the at least one tray includes a lower traystackable with an upper tray and wherein the lower tray includes thesurgical site preparation module.
 15. A method as in claim 1, whereinthe at least one tray is a single tray.
 16. A method as in claim 1,wherein the at least one tray includes a combination of stacked andunstacked trays.
 17. A method as in claim 1, wherein the at least onetray includes a bowl compartment integrally formed with the at least onetray.
 18. A method as in claim 17, wherein the bowl compartment supportsa separable bowl.
 19. A method as in claim 18, wherein the bowlcompartment includes a sterile seal on an upper surface of the at leastone tray and the bowl compartment supports liquid within the tray.
 20. Amethod of providing a modularized bundle of equipment for arecanalization procedure for decreasing preparation and surgical timefor a recanalization procedure in the treatment of acute stroke, themethod comprising the steps of: providing at least one tray having aplurality of compartments containing a plurality of equipment modulescomprising sterilized surgical equipment for surgical site preparation,and arterial access for a recanalization procedure and providing thecompartments with outer packaging to provide a sterile seal to theequipment modules enabling members of a surgical team to initiatepreparatory steps of the recanalization procedure without requiringassembly of a complete medical team, wherein the plurality of equipmentmodules comprise a surgical site preparation module having at least onecompartment containing cleaning and draping equipment including at leastone surgical drape for a distal arterial access site and cleaningsolution, the plurality of equipment modules further comprising anarterial access module having at least one compartment containingequipment including at least one of a scalpel, a local anestheticsyringe, local anesthetic, a puncture needle, forceps and an introducerwire.